CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Abraxane (nab-paclitaxel) — Coverage Criteria

Defines accepted indications, contraindications, exclusions, and coding for Abraxane (nab-paclitaxel) for oncology indications and explains when Evolent (for Neighborhood Health Plan of Rhode Island) will authorize use based on FDA labeling, compendia, or guideline support.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAbraxane (nab-paclitaxel) — Coverage Criteria

Policy CodePolicy N/A

Change TypeTemplate conversionwording clarifications

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is required and requests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1179 Abraxane guideline.

Updated 'continuation request' verbiage.

J9264HCPCS code

Commercial / Medicaid / ExchangeLines of business

Pancreatic adenocarcinomaCovered indication

Breast, Cervical, Endometrial, Ovarian, Melanoma, NSCLCNot supported (w/o allergy)

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Coverage Criteria for Abraxane (nab-paclitaxel)

Pancreatic adenocarcinoma (covered)

Covered when ANY of the following are met:

Pancreatic adenocarcinoma: Abraxane (nab-paclitaxel) combined with gemcitabine may be used as neoadjuvant therapy for borderline resectable or locally advanced pancreatic adenocarcinoma, OR may be used in combination with gemcitabine for first or subsequent line therapy for recurrent/metastatic disease in members who have not received or progressed on prior Abraxane (nab-paclitaxel).

Supported per referenced clinical evidence and guideline statements.

Tumor types not supported (with allergy exception)

Not supported for the following tumor types unless the allergy exception below applies:

Breast cancer - adjuvant/neoadjuvant/metastatic: Abraxane and Abraxane-based regimens are not supported for adjuvant therapy of stages I-III breast cancer or for treatment of recurrent unresectable or metastatic breast cancer due to lack of Level 1 evidence showing superior outcomes compared to solvent-based paclitaxel (Taxol). Exception: supported if the member has a history of a severe allergic reaction/anaphylaxis to solvent-based paclitaxel (Taxol) or docetaxel (Taxotere).

KEYNOTE-355 referenced for comparable outcomes with solvent-based paclitaxel + pembrolizumab.

Cervical, endometrial, and ovarian cancers: Abraxane (nab-paclitaxel) is not supported for treatment of cervical, endometrial, or ovarian cancer due to lack of Level 1 evidence demonstrating superiority to solvent-based paclitaxel or docetaxel. Exception: supported if the member has a history of a severe allergic reaction/anaphylaxis to solvent-based paclitaxel or docetaxel.

Melanoma (unresectable/metastatic): Abraxane (nab-paclitaxel) is not supported for treatment of unresectable or metastatic cutaneous melanoma because Level 1 evidence does not show superiority to Evolent-recommended alternatives. Exception: supported if the member has a history of a severe allergic reaction/anaphylaxis to solvent-based paclitaxel or docetaxel.

Non-Small Cell Lung Cancer (NSCLC) - initial or subsequent therapy: Abraxane (with or without carboplatin and immune checkpoint inhibitors) is not supported for initial or subsequent treatment of NSCLC because trials (e.g., KEYNOTE-407) demonstrated equivalent progression-free and overall survival compared to solvent-based paclitaxel; exception: supported if the member has a history of a severe allergic reaction/anaphylaxis to solvent-based paclitaxel.

Coverage is excluded for members who experience disease progression while receiving Abraxane or an Abraxane-containing regimen. Requests that exceed the established dosing threshold are not allowable — specifically, a single dose that exceeds 260 mg/m2 if given every 3 weeks (q3w) will be denied. Investigational uses or off-label indications without sufficient evidence or acceptance by the medical community (per the policy’s evidence standards) are also excluded.

Abraxane (nab-paclitaxel) is not supported by policy for routine use in the adjuvant, neoadjuvant, or metastatic settings for several tumor types — including breast, cervical, endometrial, ovarian cancers, unresectable/metastatic cutaneous melanoma, and NSCLC — because there is a lack of Level 1 evidence demonstrating superior outcomes versus solvent-based paclitaxel or other Evolent-recommended alternatives.

For metastatic breast cancer specifically, KEYNOTE-355 demonstrated comparable outcomes for combinations using solvent-based paclitaxel versus Abraxane-containing combinations, which supports the policy position against routine Abraxane use in this setting. Similarly, randomized trials (e.g., KEYNOTE-407 in NSCLC) showed equivalent PFS and OS when comparing Abraxane and solvent-based paclitaxel regimens.

An allergy-based exception is specified: Abraxane would be supported when the member has a documented history of a severe allergic reaction/anaphylaxis to solvent-based paclitaxel (Taxol) or docetaxel (Taxotere). In such cases, Abraxane may be considered as an alternative to avoid hypersensitivity to solvent-based agents.

Regimens and Combination Therapies

Regimen	Indication / Notes	Coverage status
Abraxane (nab-paclitaxel) +/- carboplatin +/- pembrolizumab (Keytruda) or atezolizumab
Listed as a regimen evaluated for NSCLC (squamous: pembrolizumab; non‑squamous: atezolizumab) but not supported by Evolent for initial or subsequent treatment due to lack of superior outcomes vs solvent-based paclitaxel; may be allowed if history of severe allergic reaction/anaphylaxis to solvent-based paclitaxel/docetaxel.
Not covered

Regimen	Indication / Notes	Coverage status
Abraxane (nab-paclitaxel) + gemcitabine
May be used as neoadjuvant therapy for borderline resectable or locally advanced pancreatic adenocarcinoma; may be used as first- or subsequent-line therapy for recurrent/metastatic disease in patients who have not previously received or progressed on prior Abraxane.
Covered

Comparison	Key evidence / rationale	Coverage stance
Abraxane-based regimens vs solvent-based paclitaxel/docetaxel in Breast cancer
Evolent: not supported for adjuvant/neoadjuvant or metastatic breast cancer due to lack of Level 1 evidence showing superiority; KEYNOTE-355 showed comparable outcomes for pembrolizumab combinations.
Not covered (unless severe allergy to solvent-based agents)

Coding and Dose Limits

Covered HCPCS CodesHCPCSCovered

J9264

Injection, paclitaxel protein-bound particles, 1 mg

inv-06: Single dose limit (q3w)

Single-dose limit (q3w)<= 260 mg/m2 per single dose when given every 3 weeks

Exclusion triggerDosing that exceeds the single dose limit of 260 mg/m2 q3w may result in denial

Applicable scheduleLimit applies specifically to dosing given every 3 weeks (q3w)

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required and Evolent will only authorize uses supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature that meets CMS standards.

Prior authorization required for all Abraxane (nab-paclitaxel) requests
Continuation requests may be exempt if: member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse >30 days from an active authorization; and no additional medications are being added

Step Therapy

Therapeutic Step / Allergy Exception

Abraxane is generally not supported for several tumor types unless the member has a documented severe hypersensitivity/anaphylactic reaction to solvent-based paclitaxel (Taxol) or docetaxel (Taxotere). Step therapy or allergy exception must be documented when requesting Abraxane for these tumor types.

Not supported for adjuvant therapy of stages I-III breast cancer or treatment of recurrent unresectable/metastatic breast cancer unless severe allergy to solvent-based paclitaxel/docetaxel is documented

Line of Therapy Positioning

first-line | subsequent

Pancreatic - neoadjuvant or metastatic: Abraxane + gemcitabine may be used as neoadjuvant therapy for borderline resectable or locally advanced pancreatic adenocarcinoma, OR may be used as first or subsequent line therapy for recurrent/metastatic pancreatic adenocarcinoma in patients who have not received or progressed on prior Abraxane (nab-paclitaxel).

Background and Clinical Context

Abraxane is the albumin-bound formulation of paclitaxel (nab-paclitaxel) and is administered as an intravenous antineoplastic agent. The formulation was developed to avoid solvents used in conventional paclitaxel preparations and to potentially improve drug delivery.

Clinical evidence supports nab-paclitaxel combined with gemcitabine for pancreatic adenocarcinoma — this combination demonstrated improved survival in pivotal studies and is endorsed by guideline sources for neoadjuvant use in borderline resectable or locally advanced disease and for first-line or subsequent therapy in recurrent/metastatic disease. However, across multiple other tumor types, head-to-head Level 1 evidence showing superiority of Abraxane over solvent-based paclitaxel is lacking, which informs the mixed coverage stance in the policy.

Clinical Definitions and Contraindications

inv-12: Contraindication: neutrophils

Contraindication: absolute neutrophil countANC < 1,500 cells/mm3 is listed as a contraindication to Abraxane (nab-paclitaxel)

Clinical implicationDo not initiate Abraxane in patients with neutrophil counts below 1,500 cells/mm3 until counts recover

DocumentationANC should be documented in the medical record prior to administration

inv-13: Severe hypersensitivity

Contraindication: severe hypersensitivityHistory of severe hypersensitivity reactions to Abraxane (nab-paclitaxel) is a contraindication

Product-specific wordingSevere hypersensitivity reactions to Abraxane for injectable suspension (albumin-bound paclitaxel) are contraindicated